Medical device licence · 108353 · Class 3
MAC 5 RESTING ECG ANALYSIS SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 7, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 108353
- Licence holder
- Ge Medical Systems Information Technologies Inc.Milwaukee, WI, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- October 7, 2022
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MAC 5 A4
- MAC 5 A5
- MAC 5 LITE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.